The Cordis NEVO DES
September 29, 2009 – At six months, patients receiving the NEVO Sirolimus-Eluting Coronary Stent reported significantly less chest pain than those receiving the TAXUS Liberte stent, and patients also reported improvements in their overall quality of life.
Quality-of-life data from the NEVO RES I trial were released Sept. 24 at the Transcatheter Cardiovascular Therapeutics (TCT) 2009, the largest gathering of physicians focused specifically on interventional vascular treatments. These findings are particularly noteworthy given the increasing importance of quantifying quality-of-life outcomes measurements for interventional procedures as physicians and payors work to determine the optimal treatment options for patients amid an effort to control rising health care costs.
At six months, the Seattle Angina Questionnaire (SAQ) demonstrated that patients receiving NEVO experienced more freedom from patient-reported angina than those receiving the TAXUS Liberte (91.7 vs. 87.5), corresponding to 73 percent and 63 percent of patients being completely free of angina at six months. The SAQ is a statistically valid assessment tool that provides a reliable measure of several clinically relevant aspects of a patient’s quality of life, such as physical limitation, angina stability, frequency of angina systems, a patient’s satisfaction with treatment, and a patient’s perception of how their coronary disease impacts their quality of life. In the NEVO RES I trial, patients completed the questionnaire when they were initially randomized and then one and six months after treatment.
“In this unique study, patients treated with NEVO reported more relief from angina than patients treated with the TAXUS Liberte,” said John Spertus, M.D., MPH, from the Saint Luke’s Mid-America Heart Institute, who presented the data. “While these are preliminary findings that need further confirmation, this study is significant because it is the first time we have begun including patient-reported outcomes into device trials. The inclusion of these outcomes will further define and validate the quality-of-life benefits of angioplasty for our patients.”
Dr. Spertus developed the SAQ and is a leading expert in this emerging field of quality of life and assessment of response to therapy in medicine.
“The quality-of-life outcomes seen with NEVO™ in this study are intriguing,” said Campbell Rogers, M.D., chief scientific officer and global head, research and development, Cordis. “We are exploring various hypotheses to better understand why NEVO outperforms the TAXUS Liberte in this trial on both angiographic endpoints as well as why we see such favorable outcomes for several of the key quality-of-life measures included in this trial.”
NEVO is the first drug-eluting stent utilizing RES TECHNOLOGY, which incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This unique design allows drug delivery from a stent with a surface that is 75 percent bare metal upon insertion and which becomes purely bare metal following drug delivery and polymer bioresorption in approximately three months based on in vivo data. By contrast, currently marketed drug-eluting stents, including the TAXUS Liberte, have 100 percent of their surfaces coated with drug and polymer and the polymer is never fully bioabsorbed.
The SAQ is one of several quality of life measures included in the NEVO RES I clinical trial. The SF-12 Mental Component Scores showed a borderline significant improvement for NEVO at six months (52.7 vs. 50.3) and the EQ-5D Visual Analog Scales also noted a trend in favor of NEVO (76.7 vs. 73.2). There was no difference between NEVO and the TAXUS Liberte in the SAQ physical limitation or treatment satisfaction scales or the SF-12 Physical Component Score.
Dr. Spertus is compensated for his time as the lead author of the quality of life portion of the NEVO RES I trial.
The NEVO RES I study is a randomized, multi-center comparison of NEVO to the TAXUS Liberte in de novo native coronary artery lesions. The study involved 394 patients at 40 sites throughout Europe, South America, Australia and New Zealand. Patients received clinical follow-up at 30 days and six months and will be followed annually through five years.
Primary endpoint data from the NEVO RES I trial were presented at the EuroPCR meeting in May of this year. NEVO met its primary endpoint of noninferiority and demonstrated superiority to the TAXUS Liberte with respect to the primary endpoint of in-stent late lumen loss at six months. Specifically, late lumen loss was reduced by 64 percent in the NEVO arm of the trial as compared to the TAXUS Liberte arm (0.13 mm vs. 0.36 mm). Cordis said NEVO also outperformed TAXUS Liberte on a host of secondary endpoints, including stent thrombosis, target lesion revascularization, target vessel revascularization, major cardiovascular adverse events, and angiographic in-segment binary restenosis.
Data from this trial will support a regulatory filing for a CE mark in countries outside the United States.
For more information: www.cordis.com